Sumilar

Package Leaflet: Information for the Patient

Sumilar, 5 mg + 5 mg, Hard Capsules

Sumilar, 5 mg + 10 mg, Hard Capsules

Sumilar, 10 mg + 5 mg, Hard Capsules

Sumilar, 10 mg + 10 mg, Hard Capsules

Ramipril + Amlodipine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Sumilar and What is it Used For
• 2. Important Information Before Taking Sumilar
• 3. How to Take Sumilar
• 4. Possible Side Effects
• 5. How to Store Sumilar
• 6. Package Contents and Other Information

1. What is Sumilar and What is it Used For

Sumilar contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medications called ACE inhibitors (angiotensin-converting enzyme inhibitors), while amlodipine belongs to a group of medications called calcium channel blockers.

Ramipril works by:

• reducing the production of substances in the body that can increase blood pressure,
• relaxing and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body.
• Amlodipine works by:
• relaxing and dilating blood vessels.

Sumilar can be used to treat high blood pressure (hypertension) in adult patients who have their blood pressure adequately controlled when taking both active substances separately in the same doses as in Sumilar.

2. Important Information Before Taking Sumilar

When Not to Take Sumilar

• if the patient is allergic to ramipril, amlodipine (active substances), other dihydropyridine calcium channel blockers, other ACE inhibitors, or any of the other ingredients of this medication (listed in section 6). Symptoms of an allergic reaction may include:

itching, rash, difficulty swallowing or breathing, and swelling of the lips, face, throat, or tongue;

• if the patient has liver function disorders;
• if the patient has unstable heart failure after a recent heart attack;
• if the patient has experienced shock, including cardiogenic shock (due to acute heart failure);
• if the patient has a narrowing of the outflow tract from the left ventricle (e.g., severe aortic stenosis);
• if the patient has ever experienced a severe allergic reaction called angioedema. Symptoms include:

itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;

• if the patient is undergoing dialysis or other types of blood filtration. Depending on the device used, treatment with Sumilar may not be suitable;
• if the patient has kidney disease that reduces blood flow to the kidney (renal artery stenosis);
• after the 3rd month of pregnancy (see "Pregnancy and Breastfeeding");
• if the patient has abnormally low or unstable blood pressure - the doctor will recommend appropriate monitoring;
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medication containing aliskiren,
• if the patient has taken or is taking a combination medication containing sacubitril and valsartan (used to treat chronic heart failure in adults), as the risk of angioedema (rapid swelling of the subcutaneous tissue, such as the throat) increases.

If any of the above conditions apply to the patient, they should not take Sumilar. In case of doubts, the patient should consult their doctor before taking Sumilar.

Warnings and Precautions

Before starting to take Sumilar, the patient should discuss it with their doctor or pharmacist. The patient should inform their doctor if any of the following conditions apply:

• if the patient is elderly;
• if the patient has heart or kidney disorders;
• if the patient experiences sudden swelling of the face, lips, tongue, and/or throat, and difficulty breathing or swallowing. These may be symptoms of angioedema (a severe allergic reaction) - if they occur, the patient should stop taking Sumilar and contact their doctor immediately;
• if the patient is at risk of circulatory disorders in the heart or brain in case of very low blood pressure;
• if the patient has experienced significant loss of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, low-sodium diet, prolonged use of diuretics, or dialysis);
• if the patient is scheduled to undergo desensitization treatment for bee or wasp stings;
• if the patient is scheduled to receive anesthetics for surgery or dental procedures. It may be necessary to discontinue Sumilar one day in advance - the doctor will provide guidance;
• if the patient has high potassium levels in the blood (detected in a blood test);
• if the patient has collagenosis (a connective tissue disease), such as scleroderma or systemic lupus erythematosus;
• if the patient is of African descent - these patients are at increased risk of developing angioedema, and the effectiveness of ramipril may be reduced (insufficient blood pressure reduction);
• if the patient experiences a dry, persistent cough;
• if the patient is taking any of the following medications for high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan, e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney function disorders related to diabetes;
• aliskiren;
• if the patient is taking any of the following medications, as the risk of angioedema may increase:
• racecadotril, a medication used to treat diarrhea;
• medications used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medication used to treat diabetes.

The patient should inform their doctor if they are taking any of the above medications. Sumilar may affect the action of these medications:

• medications used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, epinephrine, dobutamine, or dopamine - the doctor will recommend regular blood pressure monitoring;
• rifampicin (an antibiotic used to treat tuberculosis);
• St. John's Wort (a herbal remedy used to treat depression).

The patient should inform their doctor if they are taking any of the following medications. Sumilar may increase the risk of side effects if taken with these medications:

• medications used to treat pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid);
• medications used to treat cancer (e.g., chemotherapy), such as temsirolimus;
• medications used to prevent transplant rejection, such as tacrolimus or everolimus;
• diuretics (e.g., furosemide);
• other blood pressure-lowering medications, such as aliskiren;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medications that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection, and heparin, used to thin the blood and prevent clots) - in the case of concomitant use of these medications, close monitoring of potassium levels in the blood is required;
• corticosteroids, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat heart rhythm disorders);
• medications that may affect blood cell counts;
• ketoconazole, itraconazole (antifungal medications);
• erythromycin, clarithromycin (used to treat bacterial infections);
• ritonavir, indinavir, nelfinavir (used to treat HIV-infected patients);
• verapamil, diltiazem (used to treat heart rhythm disorders and high blood pressure).

The patient should inform their doctor if they are taking any of the following medications. Sumilar may affect the action of these medications:

• medications used to treat diabetes, such as oral hypoglycemic agents and insulin. Sumilar may lower blood sugar levels. During treatment with Sumilar, the patient should closely monitor their blood sugar levels;
• lithium (used to treat mental disorders). Sumilar may increase lithium levels in the blood. The doctor will recommend regular monitoring of lithium levels in the blood;
• simvastatin (a medication used to lower cholesterol levels in the blood). Sumilar may increase simvastatin levels in the blood.

The doctor may recommend a dose change and/or take other precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When Not to Take Sumilar" and "Warnings and Precautions").

If any of the above conditions apply to the patient (or in case of any doubts), the patient should consult their doctor before taking Sumilar.

Sumilar with Food, Drink, and Alcohol

Sumilar can be taken with or without food.

Drinking alcohol while taking Sumilar may cause dizziness or a feeling of "emptiness" in the head. In case of doubts about the amount of alcohol that can be consumed while taking Sumilar, the patient should consult their doctor, as alcohol and blood pressure-lowering medications can enhance each other's effects.

While taking Sumilar, the patient should not consume grapefruits or grapefruit juice. This is because grapefruits and grapefruit juice may increase the levels of the active substance amlodipine in the blood, which may lead to unpredictable enhancement of the blood pressure-lowering effect of Sumilar.

Pregnancy and Breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medication.

Sumilar should not be taken during the first 12 weeks of pregnancy and should not be taken after the 12th week of pregnancy, as it may seriously harm the unborn child. If the patient becomes pregnant while taking Sumilar, they should inform their doctor immediately.

The doctor will recommend an alternative medication in case of planned pregnancy.

Sumilar should not be taken during breastfeeding.

Driving and Operating Machinery

Sumilar may impair the patient's ability to drive or operate machinery, as it may cause dizziness, headache, and/or fatigue. This is most likely to occur at the beginning of treatment or when the dose of Sumilar is increased. If these symptoms occur, the patient should not drive or operate machinery.

3. How to Take Sumilar

This medication should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Method of Administration

• The medication should be taken orally, once a day, at the same time, with or without food.
• The hard capsules should be swallowed whole, with a liquid (not grapefruit juice), without crushing or chewing.

Dosage

• The usual dose is 1 capsule of the prescribed strength per day.
• Depending on the effect achieved, the doctor may adjust the dose.
• The maximum dose is 1 capsule of 10 mg + 10 mg per day.

If the patient feels that the effect of the medication is too strong or too weak, they should inform their doctor.

Elderly Patients

In very elderly or frail patients, Sumilar should not be used.

Use in Children and Adolescents

Sumilar should not be used in children and adolescents under 18 years of age due to a lack of data on its safety and efficacy in this age group.

Overdose

In case of overdose, the following symptoms may occur: low blood pressure (possibly severe) with dizziness, a feeling of "emptiness" in the head, and fainting. If blood pressure drops to critical levels, shock may occur with loss of consciousness.

Even 24-48 hours after taking the medication, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

In case of overdose, the patient should immediately consult their doctor or the emergency department of the nearest hospital. The patient should not drive themselves but should ask someone to drive them or call an ambulance. The patient should bring the medication packaging with them, so the doctor knows which medication was taken.

Missed Dose

In case of a missed dose, the patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Discontinuation of Sumilar

The patient should not suddenly stop taking Sumilar or change the prescribed dose without consulting their doctor, as the condition may worsen.

In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Sumilar can cause side effects, although not everybody gets them.

If the patient experiences any of the following severe side effects, they should stop taking Sumilar and immediately consult their doctor - urgent medical attention may be required:

• swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to Sumilar (angioedema);
• severe skin reactions, including rash, ulcers in the mouth, exacerbation of existing skin conditions, redness, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

The patient should immediately inform their doctor if they experience:

• rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of compression in the chest, or more severe disorders, including heart attack or stroke;
• shortness of breath or cough - these may be symptoms of lung disorders;
• easy bruising, prolonged bleeding, bleeding of various types (e.g., bleeding from the gums), purple spots on the skin (purpura), or more frequent infections than usual, sore throat, and fever, feeling of tiredness, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders;
• severe abdominal pain, radiating to the back - this may be a symptom of pancreatitis;
• fever, chills, fatigue, loss of appetite, abdominal pain, nausea, vomiting, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage;
• concentrated urine (dark in color), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures, which may be due to inappropriate secretion of antidiuretic hormone (SIADH).

Other Side Effects:

If any of the following side effects worsen or persist for more than a few days, the patient should inform their doctor.

Frequent(occurring in less than 1 in 10 patients):

• palpitations (irregular or stronger heartbeat);
• headache, dizziness, drowsiness;
• low blood pressure (abnormally low blood pressure), orthostatic hypotension (especially when standing up quickly or sitting up from a lying position), fainting, sudden flushing (especially of the face and neck);
• dry, persistent cough, bronchitis, sinusitis, shortness of breath;
• gastritis and/or enteritis, digestive disorders, nausea, vomiting, diarrhea;
• skin rash, especially with papules;
• chest pain, fatigue, swelling (fluid accumulation in tissues);
• muscle pain, muscle cramps, swelling of the ankles;
• increased potassium levels in the blood, detected in blood tests.

Uncommon(occurring in less than 1 in 100 patients):

• vision disorders (including blurred vision, double vision);
• tinnitus (e.g., ringing in the ears);
• kidney function disorders, including acute kidney failure, urinary disorders (increased frequency and amount of urine, nocturia), worsening of proteinuria, increased levels of urea and creatinine in the blood (indicating kidney function);
• joint pain, back pain;
• weight gain or loss;
• dizziness, tremors, abnormal sensations, such as numbness, tingling, prickling, or burning of the skin (paresthesia), reduced sensation (hypoesthesia);
• mood changes, depression, anxiety, nervousness, restlessness, sleep disorders, including insomnia or drowsiness;
• bronchospasm, including exacerbation of asthma, nasal congestion or rhinitis;
• pancreatitis (rarely fatal), increased activity of pancreatic enzymes (indicating pancreatic function), detected in blood tests, intestinal angioedema (presenting with abdominal pain, vomiting, and diarrhea), abdominal pain, including gastritis;
• increased activity of liver enzymes and/or bilirubin levels (indicating liver function), detected in blood tests;
• loss of appetite (anorexia);
• fever, weakness, pain, malaise;
• transient erectile dysfunction, impotence, decreased libido in men and women;
• increased eosinophil count (a type of white blood cell), detected in blood tests;
• angina pectoris or myocardial infarction, rapid heartbeat, arrhythmias, edema of the hands or feet;
• angioedema (see above), itching, sweating, hair loss, purpura (purple spots on the skin), skin discoloration.

Rare(occurring in less than 1 in 1,000 patients):

• disorientation;
• balance disorders;
• conjunctivitis;
• glossitis (inflammation of the tongue);
• skin exfoliation, urticaria (itching rash with blisters), nail separation from the nail bed;
• hearing disorders;
• decreased red blood cell count, white blood cell count, or platelet count, or decreased hemoglobin levels, detected in blood tests;
• vasoconstriction, decreased blood flow, vasculitis;
• jaundice due to bile stasis, liver cell damage.

Very Rare(occurring in less than 1 in 10,000 patients):

• increased blood sugar levels;
• hepatitis;
• photosensitivity reactions, and changes in skin pigmentation;
• increased muscle tone;
• peripheral neuropathy;
• gingival hyperplasia (gum overgrowth).

Frequency Not Known(frequency cannot be estimated from the available data):

• concentration disorders;
• oral mucosal ulcers (aphthous stomatitis);
• low sodium levels in the blood, detected in blood tests;
• concentrated urine (dark in color), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures - SIADH (see above);
• color change of fingers and toes in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon);
• cerebrovascular disorders, including stroke, slowed or impaired reactions, burning sensation, impaired taste;
• severe skin and mucous membrane disorders with rash, blisters, and peeling of large areas of skin (toxic epidermal necrolysis), pemphigus (a skin disease with blisters), exacerbation of psoriasis (a skin disease with red, scaly patches), other types of skin rashes or mucous membrane disorders;
• bone marrow failure, decreased blood cell counts, hemolytic anemia (anemia due to increased red blood cell destruction);
• severe allergic reactions, and non-allergic reactions (anaphylactic and pseudoanaphylactic reactions), positive antinuclear antibody titer (indicating connective tissue diseases);
• acute liver failure;
• parkinsonism, including tremors, rigidity, mask-like face, slow movements, and shuffling gait.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of this medication.

5. How to Store Sumilar

The medication should be stored out of sight and reach of children.

Do not store above 25°C.

Do not use this medication after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Sumilar Contains

• The active substances of Sumilar are amlodipine and ramipril. Each hard capsule of 5 mg + 5 mg strength contains 5 mg of ramipril and 5 mg of amlodipine (as amlodipine besylate). Each hard capsule of 5 mg + 10 mg strength contains 5 mg of ramipril and 10 mg of amlodipine (as amlodipine besylate). Each hard capsule of 10 mg + 5 mg strength contains 10 mg of ramipril and 5 mg of amlodipine (as amlodipine besylate). Each hard capsule of 10 mg + 10 mg strength contains 10 mg of ramipril and 10 mg of amlodipine (as amlodipine besylate).
• Other ingredients are: microcrystalline cellulose, hypromellose, crospovidone (type B), glycerol dibehenate, gelatin, titanium dioxide (E171), indigo carmine (E132) (only in Sumilar 5 mg + 5 mg, Sumilar 5 mg + 10 mg, and Sumilar 10 mg + 10 mg).

What Sumilar Looks Like and Contents of the Package

Sumilar 5 mg + 5 mg are hard, gelatinous, light blue capsules filled with white or almost white powder or slightly compressed aggregate; capsule size - No. 3.

Sumilar 5 mg + 10 mg are hard, gelatinous capsules with a white body and blue cap, filled with white or almost white powder or slightly compressed aggregate; capsule size - No. 1.

Sumilar 10 mg + 5 mg are hard, gelatinous, white capsules filled with white or almost white powder or slightly compressed aggregate; capsule size - No. 1.

Sumilar 10 mg + 10 mg are hard, gelatinous, blue capsules filled with white powder or almost white or slightly compressed aggregate; capsule size - No. 1.

The package contains 30, 60, or 90 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria.

Manufacturer

Pharmaceutical Works Polpharma SA, ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland.

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia.

Date of Last Revision of the Package Leaflet:06/2022